Pancreatic CancerPhase 1/2NCT00683358
Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer
A Phase 1/2 study testing VEGFR1-A24-1084 (SYGVLLWEI) in people with Pancreatic Cancer and Pancreas Neoplasms, run by Tokyo University at 1 site in Japan.
Trial summary
Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Pancreatic Cancer, Pancreas Neoplasms
- What is being tested?
- VEGFR1-A24-1084 (SYGVLLWEI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteJapan
- Study dates
- May 2008to Apr 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heterozygote or homozygote of HLA-A*2402 allele
- Inoperable or recurrent pancreatic cancer with or without any prior therapy
- Difficult to continue the prior therapy due to treatment-related toxicities
- ECOG performance status 0-2
- Evaluable primary or metastatic lesion with RECIST criteria
- Clearance period from prior therapy more than 4 weeks
- Life expectancy more than 3 months
- Laboratory values as follows 2,000/μL<WBC<15,000/μL Platelet count>100,000/μL AST<150IU/L ALT<150IU/L Total bilirubin<3.0mg/dl Serum creatinine<3.0mg/dl
Who cannot join
- Pregnancy (refusal or inability to use effective contraceptives)
- Breastfeeding
- Active or uncontrolled infection
- Systemic use of corticosteroids or immunosuppressants
- Uncontrollable brain metastasis and/or meningeal infiltration
- Unhealed external wound
- Possibilities of complicated paralytic ileus or interstitial pneumonitis
- Decision of not eligible determined by principal investigator or attending doctor
Trial locations and contacts
1 site in 1 country.
Japan1 site
Research Hospital, The Institute of Medical Science, The University of Tokyo
Minato-ku, Tokyo, 108-8639
About this study
Official title: Phase Ⅰ/Ⅱ Trial of Human Leukocyte Antigen (HLA)-A*2402-Restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Gemcitabine for Advanced Pancreatic Cancer
Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.
Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.
HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).
Read the detailed description
HLA-A*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.
These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.
- Conditions
- Pancreatic Cancer, Pancreas Neoplasms
- Being tested
- VEGFR1-A24-1084 (SYGVLLWEI)
- Keywords
- cancer, pancreas, advanced, peptide, vaccination, VEGFR1, HLA, gemcitabine, IFA, Cancer of Pancreas, Neoplasms, Pancreatic, Pancreas Cancer
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEGFR1-A24-1084 (SYGVLLWEI)Biological
Also called HLA-A*2402, advanced pancreatic cancer, VEGFR1, VEGFR1-A24-1084
HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084) 1mg emulsified with Montanide ISA51 will be subcutaneously injected 2 times weekly for total 16doses concurrently with conventional dose of gemcitabine 1,000mg/m2 BSA on 1st, 2nd, 3rd, 5th, 6th, 7th weeks for advanced/inoperable pancreatic cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: VEGFR1-A24-1084 (SYGVLLWEI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)
Measured: 1 year
Secondary outcomes (2)
Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)
Measured: 1 year
Tumor regression(Imaging study, tumor marker, etc.)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2009 (estimated)
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Investigators
- Naohide Yamashita, MD, PhD, Study director, Director, Research Hospital, Institute of Medical Science, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683358
- Sponsor's protocol ID
- IMSUT-PPKVEGFR12402
- Status last verified
- Jan 2009
- First submitted
- 16 May 2008
- Last updated
- 7 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.
PubMed 17020992Nagayama H, Sato K, Morishita M, Uchimaru K, Oyaizu N, Inazawa T, Yamasaki T, Enomoto M, Nakaoka T, Nakamura T, Maekawa T, Yamamoto A, Shimada S, Saida T, Kawakami Y, Asano S, Tani K, Takahashi TA, Yamashita N. Results of a phase I clinical study using autologous tumour lysate-pulsed monocyte-derived mature dendritic cell vaccinations for stage IV malignant melanoma patients combined with low dose interleukin-2. Melanoma Res. 2003 Oct;13(5):521-30. doi: 10.1097/00008390-200310000-00011.
PubMed 14512794
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅰ/Ⅱ Trial of Human Leukocyte Antigen (HLA)-A*2402-Restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Gemcitabine for Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00683358
- Acronym / sponsor ID
- IMSUT-PPKVEGFR12402
- Conditions
- Pancreatic Cancer, Pancreas Neoplasms
- Keywords
- cancer, pancreas, advanced, peptide, vaccination, VEGFR1, HLA, gemcitabine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Study start
- May 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 23 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.
Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.
HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).
Detailed description
HLA-A*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.
These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: VEGFR1-A24-1084 (SYGVLLWEI) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Heterozygote or homozygote of HLA-A*2402 allele
- Inoperable or recurrent pancreatic cancer with or without any prior therapy
- Difficult to continue the prior therapy due to treatment-related toxicities
- ECOG performance status 0-2
- Evaluable primary or metastatic lesion with RECIST criteria
Key exclusion criteria (8 listed)
- Pregnancy (refusal or inability to use effective contraceptives)
- Breastfeeding
- Active or uncontrolled infection
- Systemic use of corticosteroids or immunosuppressants
- Uncontrollable brain metastasis and/or meningeal infiltration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VEGFR1-A24-1084 (SYGVLLWEI)Also: HLA-A*2402, advanced pancreatic cancer, VEGFR1, VEGFR1-A24-1084HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084) 1mg emulsified with Montanide ISA51 will be subcutaneously injected 2 times weekly for total 16doses concurrently with conventional dose of gemcitabine 1,000mg/m2 BSA on 1st, 2nd, 3rd, 5th, 6th, 7th weeks for advanced/inoperable pancreatic cancer patients. | Biological | 1 |
Primary outcome
PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)
Time frame: 1 year
2 secondary outcomes
Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)
Time frame: 1 year
Tumor regression(Imaging study, tumor marker, etc.)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2009.
- Background: PubMed 17020992Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.
- Background: PubMed 14512794Nagayama H, Sato K, Morishita M, Uchimaru K, Oyaizu N, Inazawa T, Yamasaki T, Enomoto M, Nakaoka T, Nakamura T, Maekawa T, Yamamoto A, Shimada S, Saida T, Kawakami Y, Asano S, Tani K, Takahashi TA, Yamashita N. Results of a phase I clinical study using autologous tumour lysate-pulsed monocyte-derived mature dendritic cell vaccinations for stage IV malignant melanoma patients combined with low dose interleukin-2. Melanoma Res. 2003 Oct;13(5):521-30. doi: 10.1097/00008390-200310000-00011.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naohide Yamashita, MD, PhD study director
Director, Research Hospital, Institute of Medical Science, Tokyo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VEGFR1-A24-1084 (SYGVLLWEI) in people with Pancreatic Cancer and Pancreas Neoplasms, run by Tokyo University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00683358, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2009.